MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM HOOD MODEL DH-28GR; GASTROSCOPE AND ACCESSORIES

Model Number	DH-28GR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the hood separated and fell into the gastrointestinal tract.The piece was retrieved and a new hood was attached to the endoscope, and the procedure was completed successfully without harm or injury.
Additional Manufacturer Narrative
During a procedure, the distal cap was visible on the endoscope screen, but when a malfunction occurs the device was not displayed.Therefore, the malfunction was easily detectable and the device was easily retrievable.The root cause is determined to be a result of product variance.Therefore, the acceptance criteria for product inspection were reviewed and updated to strengthen quality control.However, fujifilm determined that the effect was not sufficient, so the structure of this product was changed.Improvements were not applied to this lot.Fujifilm will continue to monitor complaints for similar issues.

• Brand Name: FUJIFILM HOOD MODEL DH-28GR
• Common Device Name: GASTROSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING CORPORATION; 700 konaka-cho; sano office; sano city tochigi, 32700 01; JA 3270001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885-38
• MDR Report Key: 18046062
• Report Number: 3001722928-2023-00060
• Device Sequence Number: 20689811
• Product Code: FDS
• UDI-Device Identifier: 04547410331653
• UDI-Public: (01)04547410331653(17)241231(10)2201T4
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: DH-28GR
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 2201T4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown